Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Sean P.A. Drummond, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01009112
First received: November 5, 2009
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.


Condition Intervention
Nightmares
Insomnia
Posttraumatic Stress Disorder
Behavioral: PTSD + IRT/CBT-I
Behavioral: PTSD + Supportive Care Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • nightmares and insomnia symptoms [ Time Frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • daytime (non-sleep) PTSD symptoms [ Time Frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment ] [ Designated as safety issue: No ]
  • health-related quality of life [ Time Frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT for Insomnia
Patients change their sleep times and habits in order to reduce alertness and "over thinking" when they are trying to sleep. This helps them learn how to sleep overnight in one solid block of time
Behavioral: PTSD + IRT/CBT-I
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
Other Names:
  • IRT
  • PE
  • exposure therapy
  • Cognitive Behavioral Therapy for Insomnia
Experimental: Imagery Rehearsal Therapy
Patients "rescript" the narrative of a nightmare to eliminate the distressing elements and create a new pleasant dream scene. They then rehearse this scene in their imagination at least twice each day. This reduces the frequency and intensity of the target nightmare and often reduces other nightmares, too.
Behavioral: PTSD + IRT/CBT-I
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
Other Names:
  • IRT
  • PE
  • exposure therapy
  • Cognitive Behavioral Therapy for Insomnia
Experimental: Prolonged Exposure
This behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations.
Behavioral: PTSD + IRT/CBT-I
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
Other Names:
  • IRT
  • PE
  • exposure therapy
  • Cognitive Behavioral Therapy for Insomnia
Behavioral: PTSD + Supportive Care Therapy
6 weeks of prolonged exposure + 12 weeks of supportive care therapy
Other Names:
  • PE
  • exposure therapy
Active Comparator: Suportive Care Therapy
This is an active therapy where the focus of the intervention is on helping patients better understand their emotional response to their PTSD and sleep symptoms.
Behavioral: PTSD + Supportive Care Therapy
6 weeks of prolonged exposure + 12 weeks of supportive care therapy
Other Names:
  • PE
  • exposure therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1 or more deployments to OEF or OIF
  • Exposure to Trauma
  • Nightmares 2 or more times per week
  • Insomnia for 1 month or more
  • Live in greater San Diego County region

Exclusion Criteria:

  • Use of medications for sleep or nightmares in the past 2 weeks
  • Current enrollment in psychotherapy for PTSD
  • Current or recent substance or alcohol abuse or dependence
  • Other untreated sleep disorders (e.g., sleep apnea)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009112

Locations
United States, California
Veterans Affairs San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Sean PA Drummond, PhD Veterans Medical Research Foundation & University of California San Diego
  More Information

No publications provided

Responsible Party: Sean P.A. Drummond, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01009112     History of Changes
Other Study ID Numbers: 1RC1NR011728 - 01
Study First Received: November 5, 2009
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, San Diego:
Sleep
Sleep Disorder
Veterans
Active Duty
OEF
OIF
PTSD

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014